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File Name: dpi_qld_gov_au---tickfever-msds-combavacconcentrate-3in1.asp
                                                                        MSDS Combavac 3 in 1
TICK FEVER CENTRE, WACOL

MATERIAL SAFETY DATA SHEET
COMBAVAC 3 IN 1 LIVE TICK FEVER VACCINE
CONCENTRATE

Department of Primary Industries and Fisheries, Queensland
Biosecurity
Tick Fever Centre
280 Grindle Road, Wacol Queensland 4076 Australia
Telephone: +61 7 3898 9655
Fax: +61 7 3898 9685
E-mail: tfc@dpi.qld.gov.au
Web-site: http://www.dpi.qld.gov.au/tickfever/


IDENTIFICATION

COMBAVAC 3 IN 1 LIVE TICK FEVER VACCINE
Product Name:
CONCENTRATE

Other Names: Trivalent frozen vaccine concentrate

Manufacturer鈥檚 Product Code: CON/3I1

UN Number: None allocated

Dangerous Goods Class and None allocated, no subsidiary risk
Subsidiary Risk

Hazchem Code: None allocated

Poisons Schedule Number: Not scheduled

Use: Prevention of Tick Fever (Bovine babesiosis and
Anaplasmosis) by vaccination in cattle.

Physical Description/Properties:

Appearance: Liquid blood based vaccine cryopreserved in 5 mL
polypropylene cryotubes

Boiling Point No data.

Vapour Pressure: No data

Specific Gravity: Approximately 1.01

Flammability: Does not burn

Corrosiveness: Not corrosive



Rev: 3
Ref: MSDS4
Date of Issue: 5/09/07
Page 1 of 5
MSDS Combavac 3 in 1
TICK FEVER CENTRE, WACOL

MATERIAL SAFETY DATA SHEET
COMBAVAC 3 IN 1 LIVE TICK FEVER VACCINE
CONCENTRATE


Other Properties:

Ingredients: Contains live attenuated tick fever organisms (Babesia bovis, Babesia
bigemina and Anaplasma centrale) in bovine red blood cells diluted
with glycerol/phosphate buffered saline (PBS) containing glucose and
antibiotics.

Formulation:

Vaccine Concentrate

Mixture of bovine red blood cells containing B. bovis, B. bigemina
and A. centrale 0.5mL/mL
Glycerol in PBS (Phosphate Buffered Saline) 1.5 M
Glucose 5 mM
Heparin 2.5 units/mL
Benzylpenicillin 500 units/mL
Streptomycin Sulphate 0.5 mg/mL


Vaccine Diluent

Glycerol in PBS 1.5 M
Glucose 5 mM
Benzylpenicillin 500 units/mL
Streptomycin Sulphate 0.5 mg/mL



3 in 1 Combavac Prepared Vaccine Formulation

Each 2mL dose of vaccine contains

(i) Bovine red blood cells containing Babesia bovis,
Babesia bigemina and Anaplasma centrale
Blood volume = 0.09mL
(ii) Heparin = 0.5 units
(iii) Antibiotics: benzylpenicillin = 1000 units
streptomycin sulphate = 1.0 mg
(iv) Vaccine diluent (1.5M Glycerol in PBS with glucose and
antibiotics) to 2 mL.




Rev: 3
Ref: MSDS4
Date of Issue: 5/09/07
Page 2 of 5
MSDS Combavac 3 in 1
TICK FEVER CENTRE, WACOL

MATERIAL SAFETY DATA SHEET
COMBAVAC 3 IN 1 LIVE TICK FEVER VACCINE
CONCENTRATE


HEALTH HAZARD INFORMATION


HEALTH EFFECTS No specific data are available for the product for chronic exposure
symptoms. The vaccine is non toxic and the live organisms contained
in the vaccine are harmless to humans. The vaccine is not classified
as hazardous according to the criteria of Worksafe Australia.
However the following people may be at increased risk after self-
injection:

鈥? Elderly Persons

鈥? Persons with weakened immune systems eg. Persons whose
immune system has been altered by diseases such as leukaemia,
lymphoma or through drugs and radiation or HIV or AIDS
sufferers; and

鈥? Persons whose spleen has been removed.



Acute Swallowing, skin contact, eye contact or inhalation: According to the
present state of knowledge provided that this product is handled
correctly, there is no known danger to humans. The product contains
low levels of Benzylpenicillin and Streptomycin Sulphate antibiotics
and individuals allergic to these antibiotics should avoid self-injection
or ingestion.

FIRST AID


WARNING: You should seek medical advice if accidental self-injection occurs

Self injection: Accidental self-injection may lead to an inflammatory response and
medical advice should be sought on the management of deep
injections, particularly those near a joint or associated with bruising.
If possible the application of gentle squeezing pressure with absorbent
material (eg facial tissues) at the injection site will swab up
unabsorbed vaccine. Strong squeezing of the site should be avoided.
The damaged area should be thoroughly cleansed and a topical
antiseptic applied.

Swallowed: If in mouth, thoroughly wash mouth with water, then give some water
to drink. Further measures should not be necessary.



Rev: 3
Ref: MSDS4
Date of Issue: 5/09/07
Page 3 of 5
MSDS Combavac 3 in 1
TICK FEVER CENTRE, WACOL

MATERIAL SAFETY DATA SHEET
COMBAVAC 3 IN 1 LIVE TICK FEVER VACCINE
CONCENTRATE


Eye: If this product comes into contact with eyes, hold open and wash well
with clean running water. Ensure irrigation under eyelids by
occasionally lifting them. Do not try to remove contact lenses unless
trained.

Skin: If this product comes into contact with skin, wash skin with soap and
water.

Advice to Doctor: Accidental self injection may lead to an inflammatory response and
deep injections, particularly those near a joint or associated with
bruising should be treated medically or surgically. The vaccine
contains low levels of the antibiotics Benzylpenicillin and
Streptomycin Sulphate as preservatives (approximately 500 units of
benzylpenicillin and 0.5 mg streptomycin sulphate per mL of
vaccine).

There is no convincing evidence that the organisms used in the
vaccine (Babesia bovis, Babesia bigemina and Anaplasma centrale)
are infective for humans. However related organisms present overseas
including Babesia microti and Babesia divergens have been shown to
be able to infect and cause disease especially in elderly and immune
compromised individuals. The organisms are intra-erythrocytic
parasites and the disease syndrome can resemble malaria. More
information on the zoonotic disease seen in the United States can be
found on the web-site
http://www.riaes.org/resources/ticklab/babesia.html



PRECAUTIONS FOR USE

Exposure Standards: None available

Engineering Controls: Not applicable

Personal Protection: Avoid self-injection

Flammability: Does not burn




Rev: 3
Ref: MSDS4
Date of Issue: 5/09/07
Page 4 of 5
MSDS Combavac 3 in 1
TICK FEVER CENTRE, WACOL

MATERIAL SAFETY DATA SHEET
COMBAVAC 3 IN 1 LIVE TICK FEVER VACCINE
CONCENTRATE


SAFE HANDLING INFORMATION

Storage and Transport: Store 3 in 1 live tick fever vaccine concentrate in liquid nitrogen
(-1960C)
Use personal protective equipment when handling liquid nitrogen:
1. Goggles, safety glasses or face shield for face and eye protection
2. Clean, dry leather or PVC gloves
3. Clean and dry protective clothing and safety shoes
For more information on storage and handling of non-flammable
cryogenic and refrigerated liquids refer to AS 1894-1997.

Store prepared Comabavac 3 in 1vaccine at 20 to 80 C
(refrigerate, do not freeze)

Spills: N/A non hazardous

Disposal: Dispose of empty containers and outer packaging by wrapping with
paper and putting in garbage. Discarded needles should be placed in a
designated and appropriately labelled 鈥榮harps鈥? container. The
container should be of a type to reduce the possibility of injury to
handlers during collection and disposal. Incineration is the preferred
method of disposal, otherwise 鈥榮harps鈥? should be buried at a suitable
site, such as on farm chemical disposal pit located away from
watercourses.

Fire/Explosion Hazard: N/A


OTHER INFORMATION

This MSDS has been prepared in accord with the Worksafe Australia 鈥楴ational Code for Preparation of
Material Safety Data Sheets, 1994鈥?.

CONTACT POINT
Contact an adviser at:

Department of Primary Industries and Fisheries, Queensland
Biosecurity
Tick Fever Centre
280 Grindle Road, Wacol Queensland 4076 Australia
Telephone: +61 7 3898 9655
Fax: +61 7 3898 9685
E-mail: tfc@dpi.qld.gov.au
Web-site: http://www.dpi.qld.gov.au/tickfever/



Rev: 3
Ref: MSDS4
Date of Issue: 5/09/07
Page 5 of 5

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